Cardica Submits Additional Documentation to FDA in Support of 510(k) Submission
REDWOOD CITY, Calif., Dec. 16, 2015 (GLOBE NEWSWIRE) -- Cardica, Inc. (Nasdaq:CRDC) today announced that it submitted its responses to the questions raised by the U.S. Food and Drug Administration (FDA) on Cardica’s 510(k) submission for an expanded Indication for Use for the MicroCutter XCHANGE® 30. The responses to the FDA included the results from Cardica’s new chronic animal study conducted specifically in response to one of the FDA’s questions.
Cardica designs and manufactures proprietary stapling and anastomotic devices for cardiac and laparoscopic surgical procedures. Cardica's technology portfolio is intended to reduce operating time and facilitate minimally-invasive and robot-assisted surgeries. Cardica’s MicroCutter XCHANGE® 30, includes a cartridge-based articulating surgical stapling device with a five-millimeter shaft diameter and staples, is manufactured and cleared for use in the United States for multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix. In Europe the device has applications in multiple general, gynecologic, urologic, thoracic and pediatric surgical procedures. In addition, Cardica manufactures and markets its automated anastomosis systems, the C-Port® Distal Anastomosis Systems and PAS-Port® Proximal Anastomosis System for coronary artery bypass graft (CABG) surgery, and has shipped over 56,500 units throughout the world.
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